Testicular CancerNCT02743481
Early Life Exposures in Agriculture
An observational study of Testicular Cancer and Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: The Agricultural Health Study (AHS) studied farmers and their spouses in North Carolina and Iowa. It also included people who worked with pesticides in Iowa. They answered a questionnaire and gave data about their children born since 1975. Read more about this study
- Who is it for?
- Ages 7 to 46 years
- Conditions the study is for
- Testicular Cancer, Leukemia, Lymphoma
- How many people
- 60,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2016to 15 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 46 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Offspring of Agricultural Health Study (AHS) cohort members (farmers and their spouses residing in North Carolina and Iowa, and commercial pesticide applicators residing in Iowa).
Who may be able to join
- children born to Agricultural Health Study (AHS) participants from 1975-2009.
- individuals identified through questionnaire or through the probabilistic and deterministic match to the birth registries as being the offspring of the AHS participants.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Background:
The Agricultural Health Study (AHS) studied farmers and their spouses in North Carolina and Iowa. It also included people who worked with pesticides in Iowa. They answered a questionnaire and gave data about their children born since 1975. Researchers want to link this data to public data like birth and death certificates. They want to study how early life exposures to farms are linked to cancer and other bad health outcomes.
Read more
Objective:
To study data to find links between early life farm exposure and negative health outcomes.
Eligibility:
There will be no human subjects.
Design:
Researchers will get public data in the two study states. This will come from things like:
Birth certificates
Driver s licenses
Voter registration
Death certificates
Based on these plus the AHS data, they will create a study group. It will be called Early Life Exposure in Agriculture (ELEA).
Researchers will link ELEA data to cancer data. This will identify prevalence of cancer.
They will study parents answers on the AHS. The topics include farm practices and pesticide use. They will determine ELEA exposure to pesticides.
Researchers will analyze the cancer and pesticide results and look for links.
Read the detailed description
There is increasing evidence that early life exposures may influence future health outcomes although there is a critical need to more fully understand how these may differ from exposures received later in life. The farm environment includes pesticides that have been suggested to increase cancer risk in both children and adults. A review of the literature identified crucial gaps in our knowledge and highlighted the need for accurate exposure assessment, including separate parental interviews, specific pesticide exposure questions, and semiquantitative exposure measures that can be used to confirm information obtained through questionnaires 2. Some studies suggest that the timing of exposure may be particularly important. For example, in a study of the insecticide DDT and breast cancer, researchers observed the highest risks among women exposed prior to age 14 compared to later in life 3. The agricultural environment also includes other exposures such as animals, allergens, and endotoxins. These exposures may influence immune function, particularly when exposed at a young age, and subsequently affect later cancer risk.
The Agricultural Health Study (AHS) is a prospective cohort study of farmers and their spouses residing in North Carolina and Iowa, and commercial pesticide applicators residing in Iowa. At enrollment (1993-7) women (farmers and spouses of farmers) provided information on their children born since 1975, including name, gender, SSN and dates of birth. In previous analyses conducted using Iowa AHS data only for cancer incidence and all-cause mortality in children under the age of 19, findings suggested increased risks of incident cancer among these children associated with the use of certain pesticides by their parents. The mortality analysis focused on fatal injuries sustained, indicative of the dangerous nature of working on the farm6. In collaboration with researchers at the University of Iowa, we are currently updating the previous analysis with new cancer incidence information through 2011 and information provided by the University of Iowa, which has performed a linkage to Iowa birth certificates to identify additional children born to AHS participants from 1975-2009.
With this proposal, we are proposing to further expand the linkages in Iowa to include children not previously included, and to link to the North Carolina registries for the first time to identify additional 2 births, cancer incidence and mortality. This will establish a unique cohort of agriculturally exposed offspring, with comprehensive information on their parents farming practices, as well as other information. These data will be used to evaluate the hypothesis that early life agricultural exposures influence cancer risk. Previous analyses have only focused on childhood cancers; we will include cancers diagnosed from birth through adulthood.
- Conditions
- Testicular Cancer, Leukemia, Lymphoma, Brain Cancer
- Keywords
- Pesticide, Agriculture, Cancer, Childhood, Leukemia
- Medical subject headings
- Testicular Neoplasms, Leukemia, Lymphoma, Brain Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer incidence
Cancer incidence
Measured: Birth through 2014
Mortality
Death
Measured: Birth through 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start14 Apr 2016
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Laura Beane-Freeman, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743481
- Sponsor's protocol ID
- 999916095
- Other IDs
- 16-C-N095
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2016
- Last updated
- 20 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Life Exposures in Agriculture
- ClinicalTrials.gov ID
- NCT02743481
- Acronym / sponsor ID
- 999916095
- Conditions
- Testicular Cancer, Leukemia, Lymphoma, Brain Cancer
- Keywords
- Pesticide, Agriculture, Cancer, Childhood, Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60,000 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
The Agricultural Health Study (AHS) studied farmers and their spouses in North Carolina and Iowa. It also included people who worked with pesticides in Iowa. They answered a questionnaire and gave data about their children born since 1975. Researchers want to link this data to public data like birth and death certificates. They want to study how early life exposures to farms are linked to cancer and other bad health outcomes.
Objective:
To study data to find links between early life farm exposure and negative health outcomes.
Eligibility:
There will be no human subjects.
Design:
Researchers will get public data in the two study states. This will come from things like:
Birth certificates
Driver s licenses
Voter registration
Death certificates
Based on these plus the AHS data, they will create a study group. It will be called Early Life Exposure in Agriculture (ELEA).
Researchers will link ELEA data to cancer data. This will identify prevalence of cancer.
They will study parents answers on the AHS. The topics include farm practices and pesticide use. They will determine ELEA exposure to pesticides.
Researchers will analyze the cancer and pesticide results and look for links.
Detailed description
There is increasing evidence that early life exposures may influence future health outcomes although there is a critical need to more fully understand how these may differ from exposures received later in life. The farm environment includes pesticides that have been suggested to increase cancer risk in both children and adults. A review of the literature identified crucial gaps in our knowledge and highlighted the need for accurate exposure assessment, including separate parental interviews, specific pesticide exposure questions, and semiquantitative exposure measures that can be used to confirm information obtained through questionnaires 2. Some studies suggest that the timing of exposure may be particularly important. For example, in a study of the insecticide DDT and breast cancer, researchers observed the highest risks among women exposed prior to age 14 compared to later in life 3. The agricultural environment also includes other exposures such as animals, allergens, and endotoxins. These exposures may influence immune function, particularly when exposed at a young age, and subsequently affect later cancer risk.
The Agricultural Health Study (AHS) is a prospective cohort study of farmers and their spouses residing in North Carolina and Iowa, and commercial pesticide applicators residing in Iowa. At enrollment (1993-7) women (farmers and spouses of farmers) provided information on their children born since 1975, including name, gender, SSN and dates of birth. In previous analyses conducted using Iowa AHS data only for cancer incidence and all-cause mortality in children under the age of 19, findings suggested increased risks of incident cancer among these children associated with the use of certain pesticides by their parents. The mortality analysis focused on fatal injuries sustained, indicative of the dangerous nature of working on the farm6. In collaboration with researchers at the University of Iowa, we are currently updating the previous analysis with new cancer incidence information through 2011 and information provided by the University of Iowa, which has performed a linkage to Iowa birth certificates to identify additional children born to AHS participants from 1975-2009.
With this proposal, we are proposing to further expand the linkages in Iowa to include children not previously included, and to link to the North Carolina registries for the first time to identify additional 2 births, cancer incidence and mortality. This will establish a unique cohort of agriculturally exposed offspring, with comprehensive information on their parents farming practices, as well as other information. These data will be used to evaluate the hypothesis that early life agricultural exposures influence cancer risk. Previous analyses have only focused on childhood cancers; we will include cancers diagnosed from birth through adulthood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 46 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Offspring of Agricultural Health Study (AHS) cohort members (farmers and their spouses residing in North Carolina and Iowa, and commercial pesticide applicators residing in Iowa).
Key inclusion criteria (2 listed)
- children born to Agricultural Health Study (AHS) participants from 1975-2009.
- individuals identified through questionnaire or through the probabilistic and deterministic match to the birth registries as being the offspring of the AHS participants.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cancer incidence
Time frame: Birth through 2014
Cancer incidence
Mortality
Time frame: Birth through 2014
Death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Beane-Freeman principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Cancer and Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer incidence (time frame: Birth through 2014). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.